SNAP AF-52 - An Ambidirectional Observational Study to Assess Label-Concordant Dosing and Medication Adherence (Proportion of Days Covered) for Oral Anticoagulants in Adults Aged ≥65 Years With Atrial Fibrillation Managed in Family Health Centers in Ordu, Türkiye, With Same-Day Tertiary Cardiology Referral for Unsafe Findings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Primary Outcome 1: Label-Concordant Dose Proportion
研究概览
简要总结
SNAP AF-52 is an ambidirectional observational registry conducted in family health centers (primary care) across Ordu, Türkiye, enrolling adults ≥65 years with a pre-existing diagnosis of atrial fibrillation. The study assesses (a) label-concordant dosing of oral anticoagulants (DOACs/warfarin) using drug-specific criteria, and (b) medication adherence via Proportion of Days Covered (PDC) over the prior 12 months (good adherence defined as PDC ≥80%). Unsafe findings (e.g., suspected under-/overdosing, critical drug-drug interactions, very low renal function) trigger same-day referral to tertiary cardiology for evaluation and management. The retrospective window is Dec 1, 2024-Nov 30, 2025; the prospective single-visit inclusion window is Dec 1, 2025-May 31, 2026. No experimental treatment is administered; all care is routine.
详细描述
Family physicians will screen their ≥65-year attendees with documented AF and record a minimum dataset during a single routine visit: demographics, body weight, most recent serum creatinine (date/value) to compute Cockcroft-Gault creatinine clearance (CrCl), current oral anticoagulant and regimen, common interacting drugs, and pharmacy dispensing dates with days' supply for the last 12 months. The system auto-classifies dose appropriateness per drug label criteria (including apixaban reduction rules; rivaroxaban/dabigatran/edoxaban CrCl thresholds and P-gp/CYP3A4 interactions) and computes PDC with carry-over of early refills; primary nonadherence is defined as no fill within 30 days of the first prescription. Retrospective capture of events includes ischemic stroke/TIA/systemic embolic event (SEE) and hemorrhagic stroke/ISTH major bleeding, plus on-treatment status at the event date.
Participants with potentially unsafe dosing or clinically high-risk interaction (e.g., strong inducers; strong dual inhibitors) or CrCl <15 mL/min are same-day referred to tertiary cardiology. Identifiable data will be stored securely per ethics approval and Turkish data protection (KVKK); only aggregated results will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years.
- •Established atrial fibrillation (any type) documented in the medical record.
- •Presenting to a family health center (primary care) in Ordu province during the prospective window or having records within the retrospective window.
- •On an oral anticoagulant (DOAC) at any time in the 12-month window.
排除标准
- •Mechanical prosthetic heart valve or moderate-to-severe rheumatic mitral stenosis
- •Participation in an interventional drug study affecting anticoagulation
- •Lack of minimal data elements required for dose classification (age, sex, body weight, serum creatinine with date, current OAC and regimen)
- •Investigator judgment that reliable data cannot be obtained from records
研究组 & 干预措施
Retrospective Records Cohort
Adults aged ≥65 years with atrial fibrillation and any oral anticoagulant use documented within Dec 1, 2024-Nov 30, 2025. Data are abstracted from existing records to determine dose appropriateness at the index regimen and 12-month PDC, and to capture ischemic (I63/G45/I74) and hemorrhagic (I60-I62; ISTH major) events. No patient contact and no protocol-assigned treatment.
结局指标
主要结局
Primary Outcome 1: Label-Concordant Dose Proportion
时间窗: At index visit (assessed using baseline variables and the most recent renal function).
Proportion of patients on label-concordant dose vs underdose vs overdose, by anticoagulant. Criteria include: Apixaban: 5 mg BID (standard) or 2.5 mg BID if ≥2 of: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL. Rivaroxaban: 20 mg QD if CrCl ≥50 mL/min; 15 mg QD if CrCl 15-49; avoid/evaluate if CrCl \<15. Dabigatran: 150 mg BID (standard); 110 mg BID considered if age ≥80 or if CrCl 30-50 and P-gp inhibitor; avoid/evaluate if CrCl \<30. Edoxaban: 60 mg QD (standard); 30 mg QD if CrCl 15-50, weight ≤60 kg, or specific P-gp inhibitors (e.g., dronedarone, verapamil, erythromycin, ketoconazole, cyclosporine); consider reduced efficacy if CrCl \>95.
Primary Outcome 2: Good Adherence (PDC ≥80%)
时间窗: Prior 12 months relative to index date
Proportion of Days Covered (PDC) = (covered days / 365), with early refill carry-over and single-day duplicate fills not double-counted. Good adherence: PDC ≥80% (class-level and drug-specific PDC reported).
次要结局
- Secondary Outcome 3: Hemorrhagic Events(Prior 12 months)
- Secondary Outcome 2: Ischemic Events(Prior 12 months.)
- Secondary Outcome 1: Primary Nonadherence(From first prescription within the 12-month)
- Secondary Outcome 4: Same-Day Tertiary Referral Rate(At index visit)